Z-1194-2019 Class II Terminated
FDA device recall Z-1194-2019 was initiated by Roche Diagnostics Corporation on March 18, 2019 and is designated Class II. Reason for recall: The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. The recall status is terminated (terminated August 28, 2020). Affected quantity: 774.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 18, 2019
- Termination Date
- August 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 774
Product Description
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Reason for Recall
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Distribution Pattern
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Code Information
Catalog Number 05975573190 Lot Number 35651401